Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-04-22 @ 11:03 AM
Study NCT ID:
NCT02669303
Status:
TERMINATED
Last Update Posted:
2017-06-28
First Post:
2015-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet-rich Plasma (PRP) Injection for Treating Shoulder Subacromial Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'low recruitment rate and high rate of loss-to-followup', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-27', 'studyFirstSubmitDate': '2015-10-15', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant-Murley Total Score', 'timeFrame': '6 months post-injection', 'description': 'The sum of scores from different domains of Constant-Murley Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Constant-Murley Pain Score', 'timeFrame': '6 months post-injection', 'description': 'Pain score derived from Pain domain of Constant-Murley Questionnaire'}, {'measure': 'Constant-Murley Function score', 'timeFrame': '6 months post-injection', 'description': 'Function score derived from function domain of Constant-Murley Questionnaire'}, {'measure': 'Constant-Murley ROM score', 'timeFrame': '6 months post-injection', 'description': 'Range of motion assessment score derived from range of motion domain of Constant-Murley Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subacromial injection', 'methylprednisolone', 'treatment', 'Platelet-rich plasma'], 'conditions': ['Shoulder Impingement Syndrome']}, 'referencesModule': {'references': [{'pmid': '21422467', 'type': 'BACKGROUND', 'citation': 'Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.'}, {'pmid': '15779147', 'type': 'BACKGROUND', 'citation': 'Anitua E, Andia I, Sanchez M, Azofra J, del Mar Zalduendo M, de la Fuente M, Nurden P, Nurden AT. Autologous preparations rich in growth factors promote proliferation and induce VEGF and HGF production by human tendon cells in culture. J Orthop Res. 2005 Mar;23(2):281-6. doi: 10.1016/j.orthres.2004.08.015.'}, {'pmid': '20044683', 'type': 'BACKGROUND', 'citation': 'Karthikeyan S, Kwong HT, Upadhyay PK, Parsons N, Drew SJ, Griffin D. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement. J Bone Joint Surg Br. 2010 Jan;92(1):77-82. doi: 10.1302/0301-620X.92B1.22137.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether injection of platelet-rich plasma derived from patient's blood is effective in treatment of shoulder subacromial impingement syndrome as compared to the current protocol of methylprednisolone injection.", 'detailedDescription': 'Patients presenting with shoulder pain to the study location will be screened by the principal investigator. Once diagnosed clinically with shoulder subacromial impingement syndrome, they will be invited to join the study. They will be invited to separate academic office to be explained about the study, its voluntary and confidential basis as per our Institutional Review Board (IRB) approved protocols.\n\nAfter signing informed consent form and recruitment, they will be assigned randomly to one of the study arms through software-generated sequential allocation packaged in an opaque envelope. All involved except the principal investigator and patient are blinded.\n\nThere are two groups/arms in the study. The experimental arm will include subacromial injection of study subjects with autologous platelet-rich plasma; wheres subjects in the other study arm will be injected with methylprednisolone.\n\nThe outcome will be assessed through three scores. The study subjects will be asked to complete Oxford Shoulder Score questionnaire and health-related quality of life SF-36 questionnaire and Constant-Murley score will be measured through physician-based assessment done by the residents involved in the study. This will be done during the baseline visit before injection and repeated at 2, 6, 12 weeks and 6 months follow-up visits.\n\nAlso any adverse effects of both treatment arms will be monitored and reported as appropriate.\n\nThe investigators hypothesize that injecting platelet-rich plasma into the subacromial space of patients with subacromial impingement will result in decreased pain and increased function at 6 months follow-up (assessed by Constant-Murley Score, Oxford Shoulder Score, and Short Form-36 (SF-36) questionnaire) as compared to patients injected with methylprednisolone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult male or female between 18 and 65 years of age, inclusive, with clinical diagnosis of shoulder subacromial impingement\n\nExclusion Criteria:\n\n* Age below 18 or above 65 years\n* History of prior shoulder injections or surgery\n* History of fracture of the acromion, clavicle, scapula, or proximal humerus\n* Known allergy to corticosteroids\n* Known allergy to lidocaine'}, 'identificationModule': {'nctId': 'NCT02669303', 'acronym': 'ShIP', 'briefTitle': 'Platelet-rich Plasma (PRP) Injection for Treating Shoulder Subacromial Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome', 'orgStudyIdInfo': {'id': 'SUR.MA.134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'platelet-rich plasma group', 'description': 'Autologous platelet-rich plasma subacromial injection', 'interventionNames': ['Drug: platelet-rich plasma group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone group', 'description': 'Methylprednisolone subacromial injection', 'interventionNames': ['Drug: Methylprednisolone group']}], 'interventions': [{'name': 'platelet-rich plasma group', 'type': 'DRUG', 'otherNames': ['autologous platelet-rich plasma', 'PRP'], 'description': 'Once randomized to platelet-rich plasma arm, the study subject will have 30cc of blood drawn and centrifuged using the "Recover(TM) Platelet Separation Kit" (Biomet Biologics, Warsaw, Indiana, USA). The extracted platelet-rich plasma part will be re-injected into the subacromial space of the subject\'s affected shoulder.', 'armGroupLabels': ['platelet-rich plasma group']}, {'name': 'Methylprednisolone group', 'type': 'DRUG', 'otherNames': ['methylprednisolone acetate'], 'description': 'Once randomized to Methylprednisolone arm, the study subject will have an injection with 2ml of Methylprednisolone (40mg/ml methylprednisolone acetate injectable suspension) (Pharmacia Upjohn, Kalamazoo, Michigan, USA) with 2ml of lidocaine hydrochloride 2% (Hameln Pharmaceuticals Ltd, Gloucester, UK) into the subacromial space of their affected shoulder.', 'armGroupLabels': ['Methylprednisolone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11-236', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Muhyeddine Al-Taki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Surgery', 'investigatorFullName': 'Muhyeddine Al-Taki', 'investigatorAffiliation': 'American University of Beirut Medical Center'}}}}